Why it was recalled
Lack of Assurance of Sterility: Potential presence of leaks originating from the Connector Assembly component.
Product description
Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose, For Intraperitoneal Administration Only, 6000 mL per bag, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA. NDC: 0941-0457-01
Lot numbers, UPCs & expiration codes
Lot R24B25FA; Exp. 2/28/2026
Where it was sold
US Nationwide, Canada
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0587-2024
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Jun 17, 2024
- FDA report date
- Jul 17, 2024
- Quantity
- 6,874 bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Baxter Healthcare Corporation
Original FDA data
Every field from FDA enforcement report D-0587-2024, exactly as published.
Show all FDA fields
- City
- Deerfield
- State
- IL
- Status
- Ongoing
- Country
- United States
- Event ID
- 94846
- Address
- 1 Baxter Pkwy
- Code information
- Lot R24B25FA; Exp. 2/28/2026
- Postal code
- 60015-4625
- Report date
- Jul 17, 2024
- Product type
- Drugs
- Recall number
- D-0587-2024
- Classification
- Class II
- Recalling firm
- Baxter Healthcare Corporation
- Product quantity
- 6,874 bags
- Reason for recall
- Lack of Assurance of Sterility: Potential presence of leaks originating from the Connector Assembly component.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose, For Intraperitoneal Administration Only, 6000 mL per bag, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA. NDC: 0941-0457-01
- Distribution pattern
- US Nationwide, Canada
- Recall initiation date
- Jun 17, 2024
- Initial firm notification
- Letter
- Center classification date
- Jul 6, 2024